MedPath

Peripheral Nerve Stimulation (PNS) to optimize military performance during and after sleep deprivatio

Conditions
menselijk presteren
increasing alertness
Human performance
Registration Number
NL-OMON53207
Lead Sponsor
TNO
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

1. The potential subject has given informed and written consent and is able to
comply with all study assessments scheduled in the protocol.
2. All subjects need to be between 18 and 55 years of age.
3. All subjects have computer skills.
4. All subjects declare to be in good health, and declare not to have any
chronic diseases.
5. Subjects must be able to communicate, participate, and comply with the
requirements of the entire study.
6. One week prior to starting every trial day, all subjects need to be (and
remain) in the same time zone as the CET time zone in which the research center
lies. (GMT+1, daylight savings GMT+2). This to exclude jet lags which may
confound the test results.
7. No signs of flue or viral infection in the last 5 days before the start.
8. Participant is active military personnel

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

1. Pregnancy
2. Atherosclerosis
3. Other cardiovascular health issues
4. Epilepsy and a history of psychiatric illness (including sleeping
disorders).
5. Having an active implantable (metallic) device.
6. Using another device at the same time of testing or any portable electronic
device (e.g., mobile phone).
7. Used alcohol the day before the start of a test day.
8. Used drugs in the last 3 months.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Cognitive performance on the cognitive task battery (e.g., reaction time, false<br /><br>alarms, lapses) </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- VR test, including the percentage of decisions properly made as measured<br /><br>with a checklist for video-analysis. Quality of performance is also graded by<br /><br>instructors who are present during the VR test.<br /><br>- Sleepiness levels after each cognitive performance test<br /><br>- Mood ratings (pre- and post tests)<br /><br>- Positive- and Negative affect ratings (pre- and post tests)<br /><br>- Mental effort ratings after each cognitive performance test<br /><br>- Symptoms of motion sickness after the VR test</p><br>
© Copyright 2025. All Rights Reserved by MedPath